Tranexamic Acid Mist for Tonsillar Bleeding

(TEAPOT Trial)

Overseen By Stephanie Perez, MHA

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Bleeding disorders, Pregnancy, Allergies, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 hour

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special mist medicine, nebulized tranexamic acid (TXA), can stop bleeding in children after tonsil removal. Post-surgery bleeding sometimes occurs, and the trial seeks to find out if the mist can prevent additional surgery or a blood transfusion. Children who have recently had their tonsils removed and experience bleeding more than a day after surgery might be suitable for this trial. Participants will receive either the TXA mist or a placebo mist (saline solution) to compare outcomes. This trial could potentially make recovery smoother and safer for children. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, allowing participants to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nebulized tranexamic acid (TXA) is generally safe for treating bleeding after tonsil removal in both children and adults. Several studies reported only minor side effects, and participants tolerated the treatment well. For example, research involving both children and adults found that TXA mist effectively stopped bleeding after tonsil surgery without causing major problems. Additionally, TXA is already approved for use in other forms, such as through an IV, suggesting it is generally safe when used correctly. These findings indicate that nebulized TXA could be a safe option to manage bleeding after tonsil surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of nebulized tranexamic acid (TXA) for tonsillar bleeding because it offers a novel delivery method for this condition. Unlike traditional treatments that might involve systemic administration of TXA, nebulizing the medication allows it to be delivered directly to the site of bleeding, potentially enhancing its effectiveness while minimizing systemic exposure. This targeted approach could lead to faster control of bleeding and fewer side effects, which is why it's generating interest in the medical community.

What evidence suggests that nebulized tranexamic acid is effective for tonsillar bleeding?

This trial will compare the effectiveness of nebulized Tranexamic Acid (TXA) with nebulized saline for managing bleeding after tonsil surgery. Research has shown that a mist of TXA can effectively stop bleeding post-tonsillectomy. In one study, 77.8% of patients stopped bleeding after using TXA without experiencing harmful side effects. Another study found that more than 60% of patients stopped bleeding after using the TXA mist. This treatment not only helps stop bleeding but also reduces the likelihood of needing additional surgery. Overall, TXA is a promising and safe option for managing bleeding after tonsil surgery. ^{5 6 7 8 9}

Who Is on the Research Team?

Andrew D Meyer, MD, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for children who have had their tonsils removed and are experiencing bleeding afterwards. It's important that they haven't had any reactions to tranexamic acid before, and they aren't currently taking medication that affects blood clotting.

Inclusion Criteria

I have had my tonsils removed.

My child is between 2 and 17 years old and had a tonsillectomy.

I am experiencing bleeding after a tonsil removal surgery.

Exclusion Criteria

Intubation prior to enrollment

Previously enrolled patients.

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three consecutive doses of nebulized tranexamic acid (TXA) to manage post-operative tonsillectomy hemorrhage

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and recurrence of hemorrhage

7 days

2 visits (in-person)

Long-term Follow-up

Participants are monitored for recurrence of post-tonsillectomy hemorrhage and other outcomes

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study is testing a mist medicine called nebulized tranexamic acid (TXA) against normal saline to see if TXA can stop post-operative bleeding in kids without additional surgery or the need for blood transfusions.

How Is the Trial Designed?

Group I: Nebulized Tranexamic Acid Experimental Treatment 1 Intervention

Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Group II: Nebulized Saline Placebo Group 1 Intervention

Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35988367/

Efficacy of tranexamic acid (TXA) for post-tonsillectomy ... No adverse effects were noted with TXA administration. TXA usage provided resolution of the PTH in 77.8 % of patients. No significant ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587621001956

Post-tonsillectomy hemorrhage control with nebulized ... Fourteen out of 58 PTH patients received nebulized TXA. Receiving nebulized TXA had no adverse events and over 60% showed resolution of bleeding on exam.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/00034894251344380

The Use of Tranexamic Acid for Post-tonsillectomy ... Recent studies have demonstrated TXA's effectiveness in reducing severe epistaxis in the emergency department. However, there is limited ...

4. scholarlyexchange.childrensmercy.org scholarlyexchange.childrensmercy.org/cgi/viewcontent.cgi?article=1009&context=research_month2024

The use of Tranexamic Acid for control of post- ... 2-4. ➢The goal of this study is to determine whether nebulized TXA is safe and effective in controlling PTH and decreasing the need for surgical hemostatic.

5. scholars.northwestern.edu scholars.northwestern.edu/en/publications/treatment-of-post-tonsillectomy-hemorrhage-with-nebulized-tranexa

Initial Investigation of a Novel Therapeutic Modality All results were statistically significant. Conclusions: Our study supports nebulized TXA as an effective, non-invasive mode of hemostasis in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8143824/

Nebulized Tranexamic Acid for Pediatric Post-tonsillectomy ... Our two cases add additional data on the safety of nebulized TXA and possible effectiveness for the treatment of post-tonsillectomy hemorrhage. A multicenter ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468548822000182

Use of nebulized tranexamic acid in adult and pediatric ... We report the use of nebulized tranexamic acid (TXA) in two adult and two pediatric patients who presented with post-tonsillectomy hemorrhage.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06580509

NCT06580509 | TranExamic Atomized for Pediatric Post- ... There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist ...

9. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/ohn.1300

Reducing Surgery for Pediatric Posttonsillectomy Hemorrhage ... Evaluate the use of tranexamic acid (TXA) and observation as a management option for pediatric patients presenting with posttonsillectomy hemorrhage (PTH).